The integration of wearable technology into early-phase cancer trials represents a pivotal moment in oncology research, offering the ability to transform how we assess and predict clinical outcomes for patients. Traditional methods such as the Karnofsky Performance Status (developed in 1948) and ECOG Performance Status (introduced in 1982) have been the gold standard for decades. These scales measure a patient’s functional ability on a numerical scale and are critical for evaluating eligibility for clinical trials and treatment efficacy. However, they rely heavily on subjective assessments, which can lead to variability between clinicians and fail to capture the dynamic, day-to-day realities of a patient’s life.

The Limitations of Traditional Measures

For example, the ECOG Performance Status scores patients on a scale from 0 (fully active) to 5 (deceased). While this scale is widely used, it does not account for moment-to-moment fluctuations in a patient’s physical activity or the broader context of their overall health. In a study of advanced cancer patients, clinician-assessed ECOG scores showed poor concordance with objective activity data, such as walking distance, emphasizing the need for a more reliable approach.

The Promise of Wearables in Oncology

Wearable devices, such as smartwatches and fitness trackers, offer a solution by providing continuous, real-time data on patient activity levels. By capturing metrics like step counts, walking distance, and sleep patterns, these devices provide a more objective and nuanced view of a patient’s performance status.

In one of our studies, patients with advanced cancers wore a Fitbit Inspire HR for up to six months, though the analysis focused on data from the first week of use. The findings were compelling:

• Patients who walked less than 1,200 meters per day had significantly higher mortality rates than those who exceeded this threshold.
• This metric, termed Objective Performance Status (OPS), proved to be a stronger predictor of survival than ECOG scores.

Real-World Applications of OPS

For example, in a cohort of patients with incurable lung or gastrointestinal cancers undergoing chemotherapy, those with lower daily walking distances were categorized as high-risk for 180-day mortality. The use of OPS allowed researchers to stratify patients into risk categories with greater precision than traditional methods. This finding is particularly significant because it demonstrates the potential of OPS to guide clinical decision-making, from trial eligibility to personalized treatment planning.

Expanding the Reach of Wearable Technology

The widespread adoption of wearable devices makes this approach even more feasible. As of 2024, over 224 million people globally use smartwatches, with penetration rates expected to grow significantly in the coming years. In Spain alone, 45% of respondents own a smartwatch, and nearly 70% express interest in using these devices for health purposes. This growing accessibility underscores the potential for integrating wearables into clinical research on a large scale.

The Future: Advanced Biometrics and Machine Learning

Looking ahead, the potential applications of wearable technology extend far beyond step counts. Advanced biometrics, such as heart rate variability and glucose levels, combined with machine learning models, could provide even deeper insights into patient health. For instance, machine learning algorithms are already being explored to predict hospitalization risks during treatment based on daily activity data. These models could eventually enable real-time monitoring and dynamic adjustments to treatment protocols, further personalizing patient care.

Implications for Oncology Trials

At START, we are committed to pioneering these innovations to refine trial design, improve patient selection, and enhance the overall efficiency of oncology research. By leveraging wearables, we aim to not only improve prognostic accuracy but also expand access to clinical trials for patients who might otherwise be excluded due to subjective performance assessments.

If you are exploring ways to integrate wearable technology into your clinical trials or are interested in learning more about our work with Objective Performance Status, we invite you to connect with us.

About START

Deeply rooted in community oncology centers globally, The START Center for Cancer Research provides access to specialized preclinical and Phase 1 clinical trials of novel anti-cancer agents. START clinical trial sites have conducted more than a thousand Phase 1 clinical trials, including for 43 therapies that were approved by the FDA. START represents the world’s largest roster of Principal Investigators (PIs) across its eight clinical trial sites. Committed to accelerating passage from trials to treatments, START delivers hope to patients, families, and physicians around the world. Learn more at STARTresearch.com.